GENESIS II 71420964Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03596010210128), received between Aug 9, 2017 and Jan 7, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K962137); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER TKA SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED INSTABILITY DUE TO DISASSOCIATED OF THE INSERT FROM THE TIBIAL BASE PLATE. THIS ADVERSE EVENT WAS TREATED BY REVISION SURGERY ON (B)(6) 2024 IN WHICH THE G2 CONST INSRT SZ1-2 15MM WAS EXCHANGED FOR A NEW 18MM INSERT. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 21092220 ↗
• InjuryMar 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, PATIENT EXPERIENCED INSTABILITY OF THE G2 CONST INSRT SZ1-2 15MM. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2023 TO EXCHANGE THE DEVICE WITH A NEW G2 CONST INSRT SZ1-2 21MM. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant

  MAUDE report 16479588 ↗
• InjuryDec 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT FELL WHICH CAUSED A COMPLETE PATELLAR TENDON TEAR AND DISLOCATION/SUBLUXATION OF THE KNEE IMPLANT.

  Patient problems: Joint Dislocation

  MAUDE report 8200920 ↗
• InjuryAug 9, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION WAS PERFORMED TO REPLACE THE INSERT.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 6776882 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K962137. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2021 · Sep 21, 2020 · Terminated
  Genesis (GII) - Product Usage: designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e.